Kathleen Mullin (Stamford, CT/ US), Jelena Pavlovic (Bronx, NY/ US), Susan Hutchinson (Irvine, CA/ US), Richard B. Lipton (Bronx, NY/ US), Christopher M. Jensen (Nerw Haven, CT/ US), Alexandra C. Thiry (Nerw Haven, CT/ US), Lisa Kamen (Nerw Haven, CT/ US), Vladimir Coric (Nerw Haven, CT/ US), Robert Croop (Nerw Haven, CT/ US)
Abstract text (incl. figure legends and references)
ObjectiveAssess preference for and satisfaction with open-label rimegepant as well as CGI-C over 1 year of use as a preventive treatment and acute treatment for migraine.
MethodsThis 1-year open-label extension phase of a 12-week, randomized, double-blind, placebo-controlled study (NCT03732638) included adults aged ≥18 years with a history of 4-18 moderate-severe monthly migraine attacks. Subjects completing 12 weeks of double-blind treatment with rimegepant 75 mg or placebo every other day could continue with open-label treatment with rimegepant 75 mg every other day for preventive treatment of migraine for 52 weeks; on nonscheduled dosing days, they could take rimegepant 75 mg up to once daily as needed for acute treatment. Exploratory objectives evaluated rimegepant on Preference of Medication (PoM), Satisfaction with Medication (SM), and CGI-C scales at Weeks 12 and 52 of the open-label extension phase (ie, overall study Weeks 24 and 64).
ResultsOf 741 subjects treated in the double-blind treatment phase, 603 (81.4% [rimegepant n=301, placebo n=302]) were treated in the open-label extension phase (mean age 42.6 years, 82.7% female, hx of 7.9 monthly mod-sev attacks). Percentages (95% CI) of subjects preferring rimegepant to prior migraine treatments at Week 12 (n=357) and Week 52 (n=246) were 82.6% (78.3, 86.2) and 85.2% (80.4, 89.0), respectively. Percentages (95% CI) completely satisfied with rimegepant were 32.7% (28.2, 37.6) at Week 12 and 47.2% (41.5, 53.0) at Week 52; most of the other subjects reported being very satisfied. Percentages (95% CIs) improved on the CGI-C at Weeks 12 and 52, respectively, were 95.1% (92.9, 96.7) and 98.3% (96.4, 99.2). Week 52 results are shown in the Figure.
ConclusionLarge majorities of subjects who used open-label rimegepant for both preventive treatment and acute treatment of migraine over 1 year preferred rimegepant to prior migraine medications, were satisfied with rimegepant, and experienced clinical improvement.